Bilateral Thorathic Erector Spinae Plane Block in Laparoscopic Bariatic Surgeries

NCT06812364 | Not Yet Recruiting DMC

• 1 other identifier: MD-407-2024
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to evaluate effectiveness of one-level versus two-level thoracic ESP block on intraoperative and postoperative analgesia in bariatric surgeries and to compare total opioid consumption of both groups.

Conditions

Postoperative Pain Relief

Keywords

one level ESPB; two level ESPB; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• • Comparison of mean visual analog scale scores at 24 hours postoperative between study groups

  24 hours

Secondary Outcomes (3)

• Time for first rescue analgesia in both groups

  24 hours

• b) Total opioid consumption in both groups in 24hr postoperative

  24 hours

• Failure rate in performing the block

  24 hours

Study Arms (2)

One level ESPB

Ultrasound will be sagittal placed against the target vertebral level T7 vertebrae in the lateral or sitting position and moved in approximately 3-cm lateral to the spinous process. The Erector Spinae muscle and transverse process will be then identified, and a blunted tip ,100mm, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be advanced, using the in-plane approach, in caudal -to- cephalad direction, through the inter fascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 3 ml normal saline to confirm the correct needle tip position. The block will be performed bilaterally by injecting 60 mL of 0.25% bupivacaine (30mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the T7 vertebrae

Procedure: one level ESPB

two level ESPB

The target vertebral levels are T5 transverse process (at the level of Sternal Angle, above T7 by tow vertebra) and T10 transverse process (at the level of Xiphisternal Junction, below T7 by 3 vertebrae). The block will be performed bilaterally by injecting 60mL of 0.25% bupivacaine (15mL into each of four site) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the thoracic vertebrae 5 and 10 (at the most lateral part of the transverse process) in the same technique

Procedure: two level ESPB

Interventions

one level ESPB PROCEDURE

Ultrasound will be sagittal placed against the target vertebral level T7 vertebrae in the lateral or sitting position and moved in approximately 3-cm lateral to the spinous process. The Erector Spinae muscle and transverse process will be then identified, and a blunted tip ,100mm, 20-gauge, short bevel needle (Pajunk Sonoplex, Geisingen, Germany) will be advanced, using the in-plane approach, in caudal -to- cephalad direction, through the inter fascial plane between the Erector Spinae and the underlying transverse process under strict aseptic precautions until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 3 ml normal saline to confirm the correct needle tip position. The block will be performed bilaterally by injecting 60 mL of 0.25% bupivacaine (30mL into each side) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the T7 vertebrae

One level ESPB

two level ESPB PROCEDURE

The target vertebral levels are T5 transverse process (at the level of Sternal Angle, above T7 by tow vertebra)(19) and T10 transverse process (at the level of Xiphisternal Junction, below T7 by 3 vertebrae). The block will be performed bilaterally by injecting 60mL of 0.25% bupivacaine (15mL into each of four site) into the fascial plane between the deep surface of the Erector Spinae muscle and the bilateral transverse processes of the thoracic vertebrae 5 and 10 (at the most lateral part of the transverse process) in the same technique.

two level ESPB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

included Patient age will range 18 to 60 years, Body mass index(BMI) ≥ 35 - 50 kg/m2, American Society of Anesthesiologists physical status classes II to III, scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries, with normal coagulation profile, npt allergic to amide

You may qualify if:

• Patient age ranges 18 to 60 years old
• Obese patients ; Body mass index(BMI) ≥ 35 - 50 kg/m2
• American Society of Anesthesiologists (13) physical status classes II to III
• Patients scheduled for laparoscopic bariatric surgery i.e. sleeve gastrectomy and/or Roux-en-Y gastric bypass (RYGB) surgeries

You may not qualify if:

• Refusal of regional block
• Patients with neurological, psychological disorders or those lacking cooperation.
• Patients scheduled for concomitant laparoscopic cholecystectomy or paraumbilical hernia repair or those with history of previous bariatric surgery or obstructive sleep apnea.
• Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
• Patients with bleeding disorders defined as (INR \>1.4) and/ or (platelet count \<100,000/µL)
• Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
• Patients who are allergic to amide local anesthetics

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medecine Cairo Uneversity

Cairo, Egypt

Location

Central Study Contacts

belal galal mostafa mohammed khater, dr

CONTACT

00201006540407; bilal.j.khater@students.kasralainy.edu.eg

emad mohamed ahmed abdelhafez, lecturer

CONTACT

00201096324748; dr_emad_abady@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 6, 2025
• Study Start: March 1, 2025
• Primary Completion: September 20, 2025
• Study Completion: October 20, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)